Music Therapy for Post-cardiac Surgery Pain Management

Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05098561
Collaborator
(none)
60
1
2
47.2
1.3

Study Details

Study Description

Brief Summary

Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.

Condition or Disease Intervention/Treatment Phase
  • Other: Music Treatment
N/A

Detailed Description

  1. Specific Aims:

  2. Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used.

Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.

  1. Secondary Aims:
  1. To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.

Hypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.

  1. To assess whether music therapy can increase patient satisfaction.

Hypothesis: Music therapy increases patient satisfaction.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy
Actual Study Start Date :
Oct 15, 2018
Anticipated Primary Completion Date :
Sep 21, 2022
Anticipated Study Completion Date :
Sep 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music treatment group

The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.

Other: Music Treatment
The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.

No Intervention: Control Group

No music treatment will be used. Standard pain and comfort measure only.

Outcome Measures

Primary Outcome Measures

  1. The amount of Opioid type pain medication used [In the immediate post operative period, while patient still in the ICU]

    To assess whether the use of music therapy can decrease the amount of opioid type pain medications used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing cardiac surgery via median sternotomy
Exclusion Criteria:
  • Emergency cases.

  • Patients with hearing impairment.

  • Patients with dementia or other mental status changes.

  • Patients who are clinically unstable postoperatively.

  • Patients who develop postoperative complications.

  • Patients who are non-English speaking.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Steward St. Elizabeth medical Center Brighton Massachusetts United States 02135

Sponsors and Collaborators

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

Investigators

  • Principal Investigator: Stanley Tam, Steward St Elizabeth Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanley Tam, Attending Surgeon, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT05098561
Other Study ID Numbers:
  • 00770
First Posted:
Oct 28, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 28, 2021